Label: CALACLEAR- pramoxine hydrochloride and zinc acetate lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 23, 2021

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  • SPL UNCLASSIFIED SECTION

    Humco Calamine Lotion

    Drug Facts

  • Active Ingredient

    Pramoxine HCl 1%

  • Purpose

    External Analgesic

  • Active Ingredient

    Zinc Acetate 0.1%

  • Purpose

    Skin Protectant

  • Use

    Dries the oozing and weeping and temporarily relieves pain and itching of poison ivy, poison oak, and poison sumac or other minor skin irritations.

  • Warnings

    For external use only. Use only as directed.

    Avoid contact with eyes and mucous membranes.

    Ask a doctor before using

    on children under 2 years of age.

    When using this product. Discontinue use if 

    condition worsens, does not improve or if symptoms persist for more than 7 days, or clear up and occur again within a few days. and consult a doctor.

    Keep out of reach of children. 

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • Adults and children 2 yrs. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.
    • Children under 2 years of age: Consult a doctor before use.
  • Other Information

    • store at room temperature 15 o – 30 oC (50 o – 85 oF)
  • Inactive Ingredient

    SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Purified Water.

  • GNP Label

    GNPClear.jpg

  • Leader Label

    LDRClear.jpg

  • Quality Choice Label

    QCClear.jpg

  • Sunmark Label

    SMClear.jpg

  • Publix Label

    PublixClear.jpg

  • Premiere Value Label

    PV

  • DDM Label

    DDMClear.jpg

  • CVS Label

    CVS CalaclearCVS

  • Harris Teeter Label

    HT

  • Best Choice Label

    Best Choice

  • HEB Label

    HEB

  • Equate Label

    Equate CalaclearEquate

  • WM Label

    WMClear.jpg

  • RA Label

    RAClear.jpg

  • Top Care Label

    TCClear.jpg

  • INGREDIENTS AND APPEARANCE
    CALACLEAR 
    pramoxine hydrochloride and zinc acetate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-9108-96177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/25/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/25/1998
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884manufacture(0395-9108) , analysis(0395-9108) , pack(0395-9108) , label(0395-9108)
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